PART 11 Checklist

Rule Sec. Requirement Satisfied?
11.10(a) Validation of Systems The system is validated (Documentation, Testing and Maintenance) Yes/NO/NA
11.10(k-1) Adequate controls over documentation Controls are present for the distribution, access and use of systems documentation for operation and maintenance Yes/NO/NA
11.10(d) Limiting system access System access is limited to only authorized individuals. Yes/NO/NA
11.10(i) Persons who develop,…have the education, training, and experience There is evidence of qualification (education, training or experience) for persons
who developed the system.
Yes/NO/NA
11.10(i) Persons who maintain,…have the education,training, and experience There is evidence of qualifications (education, training or experience) for persons
who maintain the system
Yes/NO/NA
11.10(i) Persons who…use…have the education, training,
and experience…
There is evidence of qualifications (education, training or experience) for persons
who use the system.
Yes/NO/NA
11.10(i) Written policies…for actions initiated
under…electronic
signatures
If electronic signatures are used, a policy is actively implemented, so that individuals
understand the significance of, and are held accountable for, their electronic
signatures.
Yes/NO/NA
11.10(a) Ability to discern invalid or altered records There is a method to detect changes made to records (including direct record changes that
bypass system controls).
Yes/NO/NA
11.10(c) Protection of records… There is a method to protect records from accidental
or deliberate damage (including direct record changes that bypass system controls
Yes/NO/NA
11.10(b) Generate accurate and complete copies…in both human readable… The system has the ability to produce complete copies of records in printed human
readable format
Yes/NO/NA
11.10(b) Generate…in…electronic form… The system has the ability to produce complete copies of records in a common
electronic format (e.g., ASCII, TXT, DOC, XLS, etc.).
Yes/NO/NA
11.10(f) Enforce permitted sequencing of steps and events… The system controls the required sequencing of steps and events, as appropriate. Yes/NO/NA
11.10(h) Use of device checks… The system checks that data entries or operating instructions originate only from
authorized locations (e.g., work‐stations),
as appropriate.
Yes/NO/NA

Source:FDA CFR Part11

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